On August 19, 2019 HedgePath Pharmaceuticals, Inc. (OTCQB:HPPI), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to inhibit the progression of cancerous and non-cancerous proliferation disorders, reported plans to change its name to INHIBITOR Therapeutics as well as a change to the ticker symbol for common and preferred stock to "INTI" from "HPPI (Press release, HedgePath Pharmaceuticals, AUG 19, 2019, View Source [SID1234538866])." Both the corporate name change and ticker symbol change are expected to be effective with the opening of trading on August 20, 2019.
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In conjunction with the corporate name change, INHIBITOR will launch a new website (www.inhibitortx.com) to showcase INHIBITOR’s vision and development strategy for SUBA-Itraconazole, a proprietary formulation of the FDA approved anti-fungal drug itraconazole designed to enable improved bioavailability compared to conventional itraconazole when used as an anti-cancer treatment, as well as novel compounds that inhibit upstream targets of the Hedgehog Pathway as treatments for cancer and non-cancerous proliferation disorders.
"Changing our name to INHIBITOR Therapeutics marks an important point of inflection for our company as we are now positioned to capitalize on several business and clinical development initiatives, offering potential catalysts for multiple value-building events during 2019 and 2020," stated Nicholas J. Virca, President and Chief Executive Officer of INHIBITOR. "In the near-term, following a pre-IND (Investigational New Drug) meeting with the Food and Drug Administration (FDA) in April this year, INHIBITOR has secured an End of Phase 2 Meeting (EOP2) with FDA scheduled for the fourth quarter of 2019 to finalize our clinical protocol and statistical analysis plan as we prepare to submit our IND application to study SUBA-Itraconazole in patients with late-stage prostate cancer. Upon IND clearance, we plan to initiate a multi-center, randomized, double-blind, placebo-controlled Phase 2b clinical trial in men with metastatic castrate-resistant prostate cancer (mCRPC) in 2020. Additionally, in 2020, we plan to hold discussions with the FDA to advance our Phase 2b clinical program to study SUBA-Itraconazole in patients with late-stage lung cancer."
Virca continued, "We are also excited to report the signing of a renewal, for an additional year, of an expanded, exclusive worldwide option agreement with the University of Connecticut to initiate pre-clinical testing in basal cell carcinoma using novel compounds (itraconazole analogues) designed to inhibit specific protein targets of the Hedgehog Pathway. We believe this technology has significant potential and could become a platform for targeting multiple cancerous and non-cancerous proliferation disorders."
About SUBA-Itraconazole
SUBA-Itraconazole is a patented formulation of itraconazole designed to enable improved absorption and significantly reduced variability compared to generic itraconazole. Research suggests that these properties offer the potential to provide reduced intra- and inter-patient variability, enable a more predictable clinical dose response, and reduce the active drug quantity required to deliver therapeutic levels into the bloodstream.
SUBA-Itraconazole is manufactured by Mayne Pharma under current Good Manufacturing Practice standards for INHIBITOR’s use in clinical trials. An affiliate of Mayne Pharma is INHIBITOR’s majority stockholder and the licensor of the SUBA-Itraconazole technology.
About University of Connecticut Itraconazole Analogues
The itraconazole analogues, which are being developed by Dr. M. Kyle Hadden, Associate Professor of Medicinal Chemistry, Department of Pharmaceutical Sciences at the University of Connecticut, have modifications to particular regions of the itraconazole scaffold. The patents and patent applications include compositions of matter claims covering the itraconazole analogues and method claims covering their use for the treatment of cancer. Data from Dr. Hadden’s laboratory suggest that certain of these analogues maintain potent Hedgehog Pathway inhibition while exhibiting improved pharmacokinetic parameters and reduced off-target side effects sometimes associated with itraconazole. Initial testing efforts are focused on BCC tumor inhibition.